Anticoagulation and Antiplatelet Management During Perioperative Period (OMAHA)

August 11, 2020 updated by: Erasme University Hospital

Anticoagulation and Antiplatelet Management During Perioperative Period : a Daily Practice Cohort Prospective Study

the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.

Study Overview

Status

Completed

Conditions

Detailed Description

the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.

the investigators want to investigate these transitions: how were they understood by patients, how were they performed, and how does this affect surgery, postoperative morbidity and mortality?

Anticoagulation for prevention of thromboembolic events will not be studied in this study.

The anesthesia team will not be particularly trained in anticoagulants and antiplatelets management to be close to actual care. In the Hospital the investigators have a guide written in 2013 in order to describe all the cases possible. The "control/ goal group" will be the patients who have undertaken strictly the protocol described for their cases in the guide.

Study Type

Observational

Enrollment (Actual)

2400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1070
        • Erasme Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient programed for elective surgery

Description

Inclusion Criteria:

  • Patients over 18 years old
  • Able to consent
  • Taking anticoagulants or antiplatelet drugs in the long term.

Exclusion Criteria:

  • Incapacitated adults
  • Minor patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of well treated patient
Time Frame: 30 days
Ratio of well treated patient
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding consequence (volume in mL)
Time Frame: 30 days
bleeding consequence (volume in mL)
30 days
Mortality Consequence
Time Frame: 30 Days
percentage of death
30 Days
Blood Test Consequence
Time Frame: 30 Days
deviation in percentage on INR
30 Days
Morbidity
Time Frame: 30 days
percentage of rehospitalisation
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Investigators

  • Principal Investigator: Olivier DURANTEAU, Resident, Erasme UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMAHA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

if ask by mail send over

IPD Sharing Time Frame

at the end of the study during 1 month

IPD Sharing Access Criteria

Academic hospital

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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